Cardiovascular DiseasesAKROBATSNCT01068834

Additional KIF6 Risk Offers Better Adherence to Statins

An observational study of Cardiovascular Diseases and Dyslipidemia, run by Medco Health Solutions, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Many patients prescribed statins to lower their cholesterol stop taking their statin over time. The purpose of this study is to determine whether providing subjects their KIF6 carrier status (associated with increased cardiovascular event risk) will improve adherence to statin medications. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiovascular Diseases, Dyslipidemia
What is being tested?: KIF6 genetic test
How many people: 1,282 participants
Where: 1 siteUnited States
Study dates: Mar 2010to Apr 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adults (> 18y/o) newly started on either a brand name or generic statin (atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin with or without ezetimibe) being followed in Medco's RationalMed® program

Who may be able to join

Men and women at least 18 years of age
New statin prescription
Medco RationalMed® Program
Data contains patient contact information (e.g. phone number)
Data contains provider contact information
Willing to sign informed consent and send KIF6 test results to their provider

Who cannot join

Statin prescription in the previous 6 months
Subject refusal to participate in this study (record reason from subject)
Physician refusal to participate in this study (record reason from provider)
Anticipated statin discontinuation within 6 months
Any condition that would prevent the subject from completing the 6 month study follow-up period
Subject with "no contact red flag"
Subject residing in NY, NJ, MA, PA

Trial locations and contacts

1 site in 1 country.

United States1 site

Medco Health Solutions, Inc
Franklin Lakes, New Jersey, 07417

Other trials in United States

About this study

Read the detailed description

Coronary Heart Disease (CHD) remains a significant problem in the US, causing about 1 of every 5 deaths in 2005. In 2009, approximately 1.3 million Americans will have a new/recurrent myocardial infarction. Coronary heart disease (CHD) includes myocardial infarction, stable or unstable angina, demonstrated myocardial ischemia detected by noninvasive testing, and a history of coronary artery procedures (such a stent or bypass). Currently, "statins" are recommended by the AHA to manage elevated low-density lipoprotein-cholesterol (LDL-C). Unfortunately, the discontinuation of statins is quite substantial. For example, a large cohort study of older patients found that 2-year statin adherence rates were approximately 40% for acute coronary syndrome patients, 36% for chronic coronary artery disease, and 25% for primary prevention and is associated with increased mortality, hospitalizations, and costs. Recently, the kinesin 6 (KIF6) gene has been associated with a 30-55% increase in cardiovascular events in individuals carrying one or two risk variants (~57% of the white population) in multiple prospective studies. Furthermore, KIF6 carriers receiving a "statin" have a substantial greater cardiovascular risk reduction (-34 to 50%) when using a "statin" compared to those that are non-carriers using a statin (6 to 20%). In this prospective, open label, trial, recruited subjects recently started on statin therapy will be provided information about their KIF6 carrier status and followed for 6 months to determine their "statin" adherence. Additionally, quality of life and factors adherence will be measured at baseline and after 6 months. Finally, pharmacy records will be evaluated for up to 1-year to determine statin discontinuation rates.

Conditions: Cardiovascular Diseases, Dyslipidemia
Being tested: KIF6 genetic test
Keywords: Adherence, Statins, Kinesin-like protein 6
Medical subject headings: Cardiovascular Diseases, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KIF6 genetic testGenetic
KIF6 carrier status with interpretation sheet provided to subject

Study groups in NCT01068834
Study group	Role	What they receive
KIF6 tested		Recruited subjects, completing a valid KIF6 test with results Receives: Genetic: KIF6 genetic test
KIF6 test naïve		Database matched cohort not receiving a KIF6 test

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of days covered with statins in subjects tested for KIF6 status compared to statin-treated subjects who are not offered the test (KIF6 test naïve)
Measured: 6 months

Secondary outcomes (7)

To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status
Measured: 6 months
To evaluate adherence rate or medication gap in KIF6 carriers compared to KIF6 test naïve
Measured: 6 months
To compare the PDC, MPR and or gap in KIF6 carriers and KIF6 non-carriers
Measured: 6 months
To compare statin discontinuation rates between KIF6 carriers, non-carriers, and KIF6 test naïve subjects
Measured: up to 12 months
Shift in PDC between non-adherent, partially adherent, and adherent (< 0.2, >0.2 to <0.8, > 0.8, respectively) between KIF6 tested and KIF6 test naïve subjects
Measured: 6 month
To compare SF-12 v2 summary measure scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS); and, a health utility index (SF-6D.), as well as, the Morisky Adherence Scale between KIF6 carriers and non-carriers
Measured: 6 months
To determine cardiovascular costs associated with PDC
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Apr 2011

First posted15 Feb 2010 (estimated)
Study startMar 2010
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01068834
Sponsor's protocol ID: AKROBATS
Acronym: AKROBATS
Status last verified: Jan 2012
First submitted: 12 Feb 2010
Last updated: 1 Feb 2012
Results posted: No
Data monitoring committee: No

Publications

Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. No abstract available.
PubMed 19075105
National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.
PubMed 12485966
Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002 Jul 24-31;288(4):462-7. doi: 10.1001/jama.288.4.462.
PubMed 12132976
Ho PM, Magid DJ, Shetterly SM, Olson KL, Maddox TM, Peterson PN, Masoudi FA, Rumsfeld JS. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. Am Heart J. 2008 Apr;155(4):772-9. doi: 10.1016/j.ahj.2007.12.011.
PubMed 18371492
Iakoubova OA, Sabatine MS, Rowland CM, Tong CH, Catanese JJ, Ranade K, Simonsen KL, Kirchgessner TG, Cannon CP, Devlin JJ, Braunwald E. Polymorphism in KIF6 gene and benefit from statins after acute coronary syndromes: results from the PROVE IT-TIMI 22 study. J Am Coll Cardiol. 2008 Jan 29;51(4):449-55. doi: 10.1016/j.jacc.2007.10.017.
PubMed 18222355
Iakoubova OA, Tong CH, Rowland CM, Kirchgessner TG, Young BA, Arellano AR, Shiffman D, Sabatine MS, Campos H, Packard CJ, Pfeffer MA, White TJ, Braunwald E, Shepherd J, Devlin JJ, Sacks FM. Association of the Trp719Arg polymorphism in kinesin-like protein 6 with myocardial infarction and coronary heart disease in 2 prospective trials: the CARE and WOSCOPS trials. J Am Coll Cardiol. 2008 Jan 29;51(4):435-43. doi: 10.1016/j.jacc.2007.05.057.
PubMed 18222353
Morrison AC, Bare LA, Chambless LE, Ellis SG, Malloy M, Kane JP, Pankow JS, Devlin JJ, Willerson JT, Boerwinkle E. Prediction of coronary heart disease risk using a genetic risk score: the Atherosclerosis Risk in Communities Study. Am J Epidemiol. 2007 Jul 1;166(1):28-35. doi: 10.1093/aje/kwm060. Epub 2007 Apr 18.
PubMed 17443022
Shiffman D, Chasman DI, Zee RY, Iakoubova OA, Louie JZ, Devlin JJ, Ridker PM. A kinesin family member 6 variant is associated with coronary heart disease in the Women's Health Study. J Am Coll Cardiol. 2008 Jan 29;51(4):444-8. doi: 10.1016/j.jacc.2007.09.044.
PubMed 18222354
Shiffman D, O'Meara ES, Bare LA, Rowland CM, Louie JZ, Arellano AR, Lumley T, Rice K, Iakoubova O, Luke MM, Young BA, Malloy MJ, Kane JP, Ellis SG, Tracy RP, Devlin JJ, Psaty BM. Association of gene variants with incident myocardial infarction in the Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 2008 Jan;28(1):173-9. doi: 10.1161/ATVBAHA.107.153981. Epub 2007 Nov 1.
PubMed 17975119

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Additional KIF6 Risk Offers Better Adherence to Statins
ClinicalTrials.gov ID: NCT01068834
Acronym / sponsor ID: AKROBATS / AKROBATS
Conditions: Cardiovascular Diseases, Dyslipidemia
Keywords: Adherence, Statins, Kinesin-like protein 6
Study type: Observational
Recruitment status: Completed
Enrolment: 1,282 participants (actual)
Lead sponsor: Medco Health Solutions, Inc.Industry (pharma, biotech, devices)
Collaborators: Celera Genomics
Study start: Mar 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 15 Feb 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
KIF6 tested	–	Genetic: KIF6 genetic testRecruited subjects, completing a valid KIF6 test with results
KIF6 test naïve	–	–Database matched cohort not receiving a KIF6 test

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults (> 18y/o) newly started on either a brand name or generic statin (atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin with or without ezetimibe) being followed in Medco's RationalMed® program

Key inclusion criteria (6 listed)

Men and women at least 18 years of age
New statin prescription
Medco RationalMed® Program
Data contains patient contact information (e.g. phone number)
Data contains provider contact information

Key exclusion criteria (7 listed)

Statin prescription in the previous 6 months
Subject refusal to participate in this study (record reason from subject)
Physician refusal to participate in this study (record reason from provider)
Anticipated statin discontinuation within 6 months
Any condition that would prevent the subject from completing the 6 month study follow-up period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KIF6 genetic testKIF6 carrier status with interpretation sheet provided to subject	Genetic	KIF6 tested

Primary outcome

Proportion of days covered with statins in subjects tested for KIF6 status compared to statin-treated subjects who are not offered the test (KIF6 test naïve)
Time frame: 6 months

7 secondary outcomes

To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status
Time frame: 6 months
To evaluate adherence rate or medication gap in KIF6 carriers compared to KIF6 test naïve
Time frame: 6 months
To compare the PDC, MPR and or gap in KIF6 carriers and KIF6 non-carriers
Time frame: 6 months
To compare statin discontinuation rates between KIF6 carriers, non-carriers, and KIF6 test naïve subjects
Time frame: up to 12 months
Shift in PDC between non-adherent, partially adherent, and adherent (< 0.2, >0.2 to <0.8, > 0.8, respectively) between KIF6 tested and KIF6 test naïve subjects
Time frame: 6 month
To compare SF-12 v2 summary measure scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS); and, a health utility index (SF-6D.), as well as, the Morisky Adherence Scale between KIF6 carriers and non-carriers
Time frame: 6 months
To determine cardiovascular costs associated with PDC
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
Background: PubMed 19075105Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. No abstract available.
Background: PubMed 12485966National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.
Background: PubMed 12132976Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002 Jul 24-31;288(4):462-7. doi: 10.1001/jama.288.4.462.
Background: PubMed 18371492Ho PM, Magid DJ, Shetterly SM, Olson KL, Maddox TM, Peterson PN, Masoudi FA, Rumsfeld JS. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. Am Heart J. 2008 Apr;155(4):772-9. doi: 10.1016/j.ahj.2007.12.011.
Background: PubMed 18222355Iakoubova OA, Sabatine MS, Rowland CM, Tong CH, Catanese JJ, Ranade K, Simonsen KL, Kirchgessner TG, Cannon CP, Devlin JJ, Braunwald E. Polymorphism in KIF6 gene and benefit from statins after acute coronary syndromes: results from the PROVE IT-TIMI 22 study. J Am Coll Cardiol. 2008 Jan 29;51(4):449-55. doi: 10.1016/j.jacc.2007.10.017.
Background: PubMed 18222353Iakoubova OA, Tong CH, Rowland CM, Kirchgessner TG, Young BA, Arellano AR, Shiffman D, Sabatine MS, Campos H, Packard CJ, Pfeffer MA, White TJ, Braunwald E, Shepherd J, Devlin JJ, Sacks FM. Association of the Trp719Arg polymorphism in kinesin-like protein 6 with myocardial infarction and coronary heart disease in 2 prospective trials: the CARE and WOSCOPS trials. J Am Coll Cardiol. 2008 Jan 29;51(4):435-43. doi: 10.1016/j.jacc.2007.05.057.
Background: PubMed 17443022Morrison AC, Bare LA, Chambless LE, Ellis SG, Malloy M, Kane JP, Pankow JS, Devlin JJ, Willerson JT, Boerwinkle E. Prediction of coronary heart disease risk using a genetic risk score: the Atherosclerosis Risk in Communities Study. Am J Epidemiol. 2007 Jul 1;166(1):28-35. doi: 10.1093/aje/kwm060. Epub 2007 Apr 18.
Background: PubMed 18222354Shiffman D, Chasman DI, Zee RY, Iakoubova OA, Louie JZ, Devlin JJ, Ridker PM. A kinesin family member 6 variant is associated with coronary heart disease in the Women's Health Study. J Am Coll Cardiol. 2008 Jan 29;51(4):444-8. doi: 10.1016/j.jacc.2007.09.044.
Background: PubMed 17975119Shiffman D, O'Meara ES, Bare LA, Rowland CM, Louie JZ, Arellano AR, Lumley T, Rice K, Iakoubova O, Luke MM, Young BA, Malloy MJ, Kane JP, Ellis SG, Tracy RP, Devlin JJ, Psaty BM. Association of gene variants with incident myocardial infarction in the Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 2008 Jan;28(1):173-9. doi: 10.1161/ATVBAHA.107.153981. Epub 2007 Nov 1.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott L Charland, PharmD principal investigator

Medco Health Solutions, Inc.

James J Devlin, PhD principal investigator

Celera Genomics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Dyslipidemia, run by Medco Health Solutions, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of days covered with statins in subjects tested for KIF6 status compared to statin-treated subjects who are not offered the test (KIF6 test naïve) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01068834, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.